Quality Engineer II

4 weeks ago

Baltimore County, United States BD Full time

Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

SUMMARY:

The Quality Engineer II has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy's for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant.

The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. Will support both internal and external audits.

Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products. Assesses Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow. Initiates CAPAs and may lead the investigation/corrective action process.
 

Responsible for day to day QM Engineering responsibilities for product and related operational areas. Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting plant trainings and initiatives.
 

RESPONSIBILITIES

This specific role will have a focus on site validations of equipment, software and materials.

Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies.

Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments.

Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans and design control.

Supports implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation in current products.

Responsible for initiating and coordinating SAP master data and documentation for product changes and new products.

Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes.

Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures.

Supports internal and external audits, and assists in administering the audit program.

Develops and maintains efficient methods for regularly reporting to management the current status of product quality with respect to Quality objectives and goals and provides plant quality metrics as required to generate quality system improvements.

Facilitates investigation of customer complaints. Implement revision to IT's based on the result of complaint analysis. Initiates preventative action plans and field action plans in response to valid customer complaints.

Defines Change Control requirements for the plant related to manufacturing, facility and material changes. May provide full support to raw material changes assuring that all Quality Systems and requirements are met.

REQUIREMENTS

Bachelor's degree. Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field.

2+ years experience in Quality, Quality Control, or Supplier Quality.

PREFERRED AND ADDITIONAL SKILLS AND QUALIFICATIONS

Experience with independently writing and executing validation protocols

Experience in a medical device or pharmaceutical manufacturing facility.

Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485

Clinical Diagnostic experience a plus

Ability and skill to effectively manage multiple tasks and drive execution of change management plans

Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC
Six sigma, additionally root cause analysis and project management techniques are routinely employed

Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience

Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations

Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.

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